Faringospray (Spray) Instructions for Use

Marketing Authorization Holder

Sun Pharmaceutical Industries, Ltd. (India)

Quality Control Release

BIOSINTEZ, PJSC (Russia)

Manufactured By

HASCO-LEK S.A. (Poland)

ATC Code

A01AD02 (Benzydamine)

Active Substance

Benzydamine (Rec.INN registered by WHO)

Dosage Form

Faringospray

Metered-dose topical spray 0.255 mg/dose: 30 ml bottle

Dosage Form, Packaging, and Composition

Metered-dose spray for topical application in the form of a transparent green liquid with a characteristic mint odor.

Excipients: glycerol, ethanol 96%, saccharin, sodium bicarbonate, methylparaben, mint flavor, polysorbate 20, quinoline yellow dye, patent blue dye, purified water.

30 ml (155 doses) – bottles – cardboard packs complete with a sprayer and nozzle.
30 ml (155 doses) – bottles (60) – cardboard boxes complete with a sprayer and nozzle.

Clinical-Pharmacological Group

NSAIDs for topical use in ENT practice and dentistry

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID, an indazole derivative, without a carboxyl group. The absence of a carboxyl group imparts the following features: Benzydamine is a weak base (whereas most NSAIDs are weak acids), has high lipophilicity, penetrates well into the site of inflammation along the pH gradient (where pH is lower) and accumulates in therapeutic concentrations.

It has an anti-inflammatory and local analgesic effect, possesses antiseptic (against a wide range of microorganisms), as well as antifungal action.

The anti-inflammatory effect is due to a decrease in capillary permeability, stabilization of cell membranes due to inhibition of the synthesis and inactivation of prostaglandins, histamine, bradykinin, cytokines, complement factors and other nonspecific endogenous damaging factors.

Benzydamine suppresses the production of pro-inflammatory cytokines, especially TNFα, and to a lesser extent IL-1β. The main feature of benzydamine is that, being a weak inhibitor of prostaglandin synthesis, it demonstrates potent inhibition of pro-inflammatory cytokines. For this reason, Benzydamine can be classified as a cytokine-suppressing anti-inflammatory drug.

The local anesthetic effect of benzydamine is associated with the structural features of its molecule, similar to local anesthetics. The analgesic effect is due to an indirect decrease in the concentration of biogenic amines with algogenic properties and an increase in the pain threshold of the receptor apparatus; Benzydamine also blocks the interaction of bradykinin with tissue receptors, restores microcirculation and reduces pain sensitivity at the site of inflammation.

Benzydamine has an antibacterial effect due to rapid penetration through the membranes of microorganisms with subsequent damage to cellular structures, disruption of metabolic processes and the function of cell lysosomes.

It has an antifungal effect against 20 strains of Candida albicans and Candida non-albicans, causing structural modifications of the fungal cell wall and their metabolic chains, thus preventing their reproduction.

Pharmacokinetics

When applied topically, it is well absorbed through the mucous membranes and quickly penetrates into inflamed tissues. It is detected in the blood plasma in an amount insufficient to obtain systemic effects. It is excreted mainly by the kidneys and through the intestines in the form of metabolites or conjugation products.

Indications

Symptomatic therapy of pain syndrome in inflammatory diseases of the oral cavity and ENT organs (of various etiologies): pharyngitis, laryngitis, tonsillitis; gingivitis, glossitis, periodontitis, stomatitis (including after radiation and chemotherapy); calculous inflammation of the salivary glands; after dental treatment or extraction; after surgical interventions and injuries (tonsillectomy, jaw fractures); candidiasis of the oral mucosa (as part of combination therapy).

ICD codes

Dosage Regimen

Use topically only. Administer by metered-dose spray into the oral cavity or oropharynx.

For adults and adolescents aged 12 years and older, administer 4 to 8 doses (1.02 – 2.04 mg benzydamine) 2 to 6 times daily.

For children aged 6 to 12 years, administer 4 doses (1.02 mg benzydamine) 2 to 6 times daily.

For children aged 3 to 6 years, administer 1 dose per 4 kg of body weight (maximum 4 doses or 1.02 mg benzydamine) 2 to 6 times daily. Do not exceed the maximum single dose.

Direct the spray toward the affected area of the oral mucosa or throat.

For gingival or periodontal application, spray the dose onto the affected area.

The duration of treatment depends on the indication and clinical response. Consult a physician if symptoms persist for more than 3 days of treatment.

Do not use in children under 3 years of age due to risk of laryngospasm.

Adverse Reactions

Local reactions: rarely – dry mouth, burning sensation in the oral cavity; frequency unknown – numbness sensation in the oral cavity.

Allergic reactions: infrequently – photosensitivity; rarely – sensitivity reactions, skin rash, skin itching; very rarely – angioedema, laryngospasm; frequency unknown – anaphylactic reactions.

Contraindications

Children under 3 years of age; children over 3 years of age (depending on the dosage form used); hypersensitivity to benzydamine.

With caution

Hypersensitivity to acetylsalicylic acid or other NSAIDs; bronchial asthma (including history).

Use in Pregnancy and Lactation

Should not be used during pregnancy and breastfeeding.

Pediatric Use

Contraindicated for use in children under 3 years of age; in children over 3 years of age – depending on the dosage form used.

Geriatric Use

There are no specific restrictions on use in elderly patients.

Special Precautions

In the presence of ulcerative lesions of the oropharyngeal mucosa, the patient should consult a doctor if symptoms persist for more than 3 days.

Not recommended for use in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs.

Use with caution in patients with bronchial asthma, as bronchospasm may develop.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.